Which agency regulates laboratory testing and standards?

The Centers for Medicare & Medicaid Services (CMS) is the agency that regulates laboratory testing and standards, particularly through the Clinical Laboratory Improvement Amendments (CLIA). CLIA established quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. This regulation is essential for promoting safe and effective laboratory practices, including phlebotomy, thus enhancing patient care.

The Food and Drug Administration (FDA) is primarily responsible for regulating food, drugs, and medical devices but does not set standards specifically for laboratory testing. The Centers for Disease Control and Prevention (CDC) focuses on public health and safety, including disease prevention and epidemiology, but does not have regulatory authority over laboratory testing. The World Health Organization (WHO) provides international public health guidance and standards but lacks regulatory power over laboratories in individual countries.

Understanding CMS's role helps phlebotomy technicians appreciate the regulatory framework that underpins their work and ensures patient safety in laboratory settings.